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Clinical Trials List

Protocol NumberD933BC00001
NCT Number(ClinicalTrials.gov Identfier)NCT03509012
Active

2018-12-01 - 2019-11-07

Phase I

Not yet recruiting1

Recruiting3

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase I Multicenter Study of Immunotherapy in Combination with Chemoradiation in Patients with Advanced Solid Tumors (CLOVER)

  • Trial Applicant

  • Sponsor

    ASTRAZENECA TAIWAN LIMITED

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/21

Investigators and Locations

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

1 Recruiting

Audit

None

Principal Investigator Inn-Wen Chong 未分科
Kaohsiung Municipal Gangshan Hospital

Co-Principal Investigator

Audit

None

Principal Investigator Chih-Liang Wang
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Carcinoma, Squamous Cell of Head and Neck Carcinoma, Non-Small-Cell Lung Small Cell Lung Carcinoma

Objectives

This is an open-label, multicenter, phase I study to evaluate the safety and tolerability of durvalumab ± tremelimumab in combination with chemoradiation in patients with advanced solid tumors

Test Drug

Durvalumab (MEDI4736)
Tremelimumab

Active Ingredient

Durvalumab
Tremelimumab

Dosage Form

Injection
Injection

Dosage

500mg/10ml/vial
400mg/20ml/vial

Endpoints

Number of subjects with Dose Limiting Toxicities (DLTs) From first dose of durvalumab until 28 days after completion of radiation therapy
Number of subjects with Adverse Events (AEs) From first dose of durvalumab up to 90 days after the last dose of study treatment

Inclution Criteria

World Health Organization (WHO)/ECOG performance status of 0 or 1
Body weight >30 kg at enrollment and treatment assignment
At least 1 measurable lesion, not previously irradiated
No prior exposure to immune-mediated therapy (including therapeutic anticancer vaccines)
For patients with oropharyngeal HNSCC HPV status has to be known

Exclusion Criteria

Patients with simultaneous primary malignancies or bilateral tumors
Active or prior documented autoimmune or inflammatory disorders
Brain metastases or spinal cord compression
Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; positive HIV 1/2 antibodies)
Has a paraneoplastic syndrome (PNS) of autoimmune nature
HNSCC cohort: Head and neck cancer that does not include unresectable, locally advanced cancer of oral cavity, larynx, oropharynx or hypopharynx. HNSCC of unknown primary are also excluded
NSCLC and SCLC cohort: Mixed SCLC and NSCLC histology
SCLC cohort: Extensive-stage SCLC

The Estimated Number of Participants

  • Taiwan

    92 participants

  • Global

    300 participants

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